CN104160035A - Test strip with stacked unidirectional contact - Google Patents

Test strip with stacked unidirectional contact Download PDF

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Publication number
CN104160035A
CN104160035A CN201380012160.1A CN201380012160A CN104160035A CN 104160035 A CN104160035 A CN 104160035A CN 201380012160 A CN201380012160 A CN 201380012160A CN 104160035 A CN104160035 A CN 104160035A
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conductive layer
test strip
analytical test
electrode part
carrier sheet
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CN201380012160.1A
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CN104160035B (en
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S.斯洛斯
R.巴恩
G.维布斯特
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Cilag GmbH International
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Cilag GmbH International
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28Electrolytic cell components
    • G01N27/30Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3272Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2400/00Assays, e.g. immunoassays or enzyme assays, involving carbohydrates

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Electrochemistry (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Diabetes (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

An analytical test strip ("ATT") for use with a test meter includes a first insulating layer, with a first insulating layer upper surface, and a first electrically conductive layer ("ECL") disposed thereon. The first ECL includes a first electrode portion ("EP") and an electrical contact pad in electrical communication with the first EP. The ATT also includes a patterned spacer layer disposed above the first ECL that includes (i) a distal portion defining a bodily fluid sample-receiving chamber therein that overlies the first EP and (ii) an insulating proximal portion with an upper surface having a second ECL disposed thereon. The second ECL includes an interlayer contact portion and an electrical contact pad. A third ECL of the ATT includes a second EP and a proximal portion that overlies the interlayer contact portion. The second EP is disposed overlying and exposed to the sample-receiving chamber in an opposing relationship to the first EP.

Description

There is the test strip of stacking unidirectional contact
Background technology
Technical field
The present invention relates generally to medical treatment device, and relate more specifically to experiment tester and methods involving.
the description of association area
In medical field in special concern fluid sample analyte determine (as detect and/or measurement of concetration).For example, in, can expecting to determine body fluid samples such as urine, blood, blood plasma or the interstitial fluid concentration of glucose, ketoboidies, cholesterol, lipoprotein, triglyceride level, paracetamol and/or HbAlc.Use can realize this type of with the hand-held experiment tester of analytical test strip (for example,, based on electrochemical analytical test strip) combination and determine.
Brief description of the drawings
Novel feature of the present invention is especially shown in appended claims.With reference to following embodiment and accompanying drawing, will understand better the features and advantages of the present invention.Embodiment has provided the exemplary embodiment that adopts the principle of the invention, identical numeral identical key element (element) in accompanying drawing, in figure:
Fig. 1 is the simplification decomposition diagram of analytical test strip according to an embodiment of the invention;
Fig. 2 is the simplified perspective view of the analytical test strip of Fig. 1;
Fig. 3 is the simplified perspective view of the distal part of the analytical test strip of Fig. 1 of contacting with experiment tester electrical connector pins;
Fig. 4 is the simplified side view of the distal part of Fig. 3;
Fig. 5 is the top view of the patterning interlayer of the analytical test strip of Fig. 1;
Fig. 6 is the top view of the 3rd conductive layer of the analytical test strip of Fig. 1;
Fig. 7 is the simplification top view with the analytical test strip claimed in claim 1 of integrated carrier sheet;
Fig. 8 is the simplification distal end view of analytical test strip and the integrated carrier sheet of Fig. 5;
Fig. 9 is the simplified cross-sectional view of analytical test strip and the integrated carrier sheet of Fig. 5; And
Figure 10 is the schema illustrating according to the stage of the method for definite body fluid sample analyte of the embodiment of the present invention.
Embodiment
The detailed description that should read in conjunction with the accompanying drawings below, wherein the numbering of the like in different accompanying drawings is identical.Each accompanying drawing may not be drawn in proportion, and the only embodiment of depicted example for purposes of illustration, is not intended to limit the scope of the invention.This detailed description by way of example and non-limiting way illustrates principle of the present invention.This explanation will clearly make those skilled in the art can prepare and use the present invention, and describe multiple embodiment of the present invention, remodeling, modification, alternative form and purposes, comprise that it is believed that is at present to implement optimal mode of the present invention.
As used herein, represent to allow the set of parts or multiple assemblies to carry out its suitable tolerance of dimension earmarking as described herein for term " about " or " approximately " of any numerical value or scope.
In general, the analytical test strip using together with experiment tester (such as, hand-held experiment tester) according to an embodiment of the invention comprises having the first insulation layer of the first insulation layer upper surface and be arranged on the first conductive layer on the first insulation layer upper surface.The first conductive layer comprises the first electrode part (such as, working electrode part) and the pad that electrically contacts with the first electrode part electric connection.Analytical test strip also comprises the patterning interlayer that is arranged on the first conductive layer top.This patterning interlayer comprises (i) distal part, and it is limited to the body fluid sample receiving chamber of covering the first electrode part wherein, and (ii) insulation portions of proximal, it has the second conductive layer upper surface disposed thereon.The second conductive layer comprises interlayer contact part and the pad that electrically contacts with interlayer contact part electric connection.
Analytical test strip also comprises the second insulation layer, and described the second insulation layer is arranged on patterning interlayer top and has the 3rd conductive layer the second insulation layer lower surface disposed thereon.The 3rd conductive layer comprises the second electrode part (all such as (e.g.) reference/counter electrode) and covers the portions of proximal of interlayer contact part.
In addition, the second electrode part of analytical test strip is divided and is arranged to cover and be exposed to sample receiving chamber, is divided into relative (, coplanar) relation with the first electrode part.In addition, portions of proximal and operationally juxtaposition of interlayer contact part, make the second electrode part and the electrically contacting between pad of described patterning interlayer at the 3rd conductive layer during using analytical test strip exist and be electrically connected.
The pad that electrically contacts that electrically contacts pad and the second conductive layer of the first conductive layer is called as stacking unidirectional contact pad.Why they are that " stacking " is because the pad that electrically contacts of the second conductive layer is elevated with respect to the pad that electrically contacts of the first conductive layer.Why they are that " unidirectional " is because therefore the two all also can touch and contact from same direction at upper surface.
Be according to the benefit of analytical test strip of the present invention: for example, their configuration (the especially stacking unidirectional character of contact pad) is not in the case of for exposing the making of obeying heavy body, high yield the special and complicated die-cut step of accurate aligning of contact pad.
Fig. 1 is the simplification decomposition diagram of analytical test strip 100 according to an embodiment of the invention.Fig. 2 is the simplified perspective view based on electrochemical analytical test strip of Fig. 1.Fig. 3 is the simplified perspective view of the part based on electrochemical analytical test strip of Fig. 1 of contacting with experiment tester electrical connector pins (ECP).Fig. 4 is the simplified side view of the part of Fig. 3.Fig. 5 is the top view of the patterning interlayer of the analytical test strip of Fig. 1.Fig. 6 is the top view of the 3rd conductive layer of the analytical test strip of Fig. 1.
Referring to Fig. 1 to Fig. 6, be used from and (for example determine body fluid sample with experiment tester one according to an embodiment of the invention, whole blood sample) in the analytical test strip 100 of analyte (such as, glucose) comprise thering is the first insulation layer 102 of the first insulation layer upper surface 104 and be arranged on the first conductive layer 106 on the first insulation layer upper surface 104.The first conductive layer 106 comprise the first electrode part 108 and with the first electrode part 108 electric connections electrically contact pad 110.
Analytical test strip 100 also comprises the patterning interlayer 112 that is arranged on the first conductive layer 106 tops.Patterning interlayer 112 has distal part 114, and distal part 114 is limited to the body fluid sample receiving chamber 116 of covering the first electrode part 108 wherein.Patterning interlayer 112 also has with the insulation portions of proximal 118 of upper surface 120 and the second conductive layer 122 disposed thereon.In addition, the second conductive layer 122 has interlayer contact part 124 and electrically contacts pad 126.
Analytical test strip 100 also comprises the second insulation layer 128 that is arranged on patterning interlayer 112 tops.The second insulation layer 128 has the second insulation layer lower surface 130.Analytical test strip 100 also comprises the 3rd conductive layer 132 in addition, described the 3rd conductive layer 132 is arranged on the second insulation layer lower surface 130, and described the second insulation layer lower surface 130 comprises the second electrode part 134 and covers the portions of proximal 136 of interlayer contact part 124.The second electrode part 134 be arranged to cover and be exposed to body fluid sample receiving chamber 116 and with 108 one-tenth relative (, coplanar) relations of the first electrode part.Analytical test strip 100 also comprises reagent layer 138 (particularly, referring to Fig. 1).
In analytical test strip 100, the operationally juxtaposition of interlayer contact part of the portions of proximal of the 3rd conductive layer and the second conductive layer, makes the second electrode part and the electrically contacting between pad of patterning interlayer at the 3rd conductive layer during using analytical test strip exist and be electrically connected.Arrange even if the first electrode part is divided into relative (that is, coplanar) with the second electrode part, this electrical connection also provides the unidirectional stacking pad that electrically contacts.
The portions of proximal of the 3rd conductive layer also can be in the following manner and operationally juxtaposition of internal layer contact part: by for example attached with electroconductive binder, or by compress gap therebetween (in the direction of the arrow A of Fig. 4) in the time inserting in experiment tester.For example, by apply scope per square inch 3 pounds realize this compression to the power in 30 pounds per square inch.Can obtain operationally juxtaposition by any known devices, these devices comprise electrical fused joint or conductive foil web member.
Electrically contacting pad 126 and 110 is configured to separately by electrically contacting and carry out operationally mutual with experiment tester with the independently electrical connector pins (being labeled as ECP in Fig. 3 and Fig. 4) of experiment tester.
The first insulation layer 102, insulation portions of proximal 118 and the second insulation layer 128 can for example, for example, be formed by () plastics (, PET, PETG, polyimide, polycarbonate, polystyrene), silicon, pottery or glass material.For example, the first insulation layer and the second insulation layer can be formed by the polyester base of 7 mils.
In the embodiment of Fig. 1 to Fig. 6, the first electrode part 108 and the second electrode part 134 are configured to well known by persons skilled in the artly anyly suitable to determine analyte (for example, the glucose in the whole blood sample) concentration in body fluid sample based on electrochemical technology with electrochemical method by using.
The first conductive layer 106, the second conductive layer 122 and the 3rd conductive layer 132 can be formed by any suitable electro-conductive material respectively, for example, such as for example gold, palladium, carbon, silver, platinum, stannic oxide, iridium, indium or their combination (, the stannic oxide of doped indium).In addition, can adopt any suitable technology to form the first conductive layer, the second conductive layer and the 3rd conductive layer, comprise for example sputter, evaporation, electroless plating, silk screen printing, contact print or intaglio printing.For example, the first conductive layer 106 can be sputter palladium layer, and the 3rd conductive layer 132 can be sputter gold layer.
The distal part 114 of patterning interlayer 112 is for combining the first insulation layer 102 (having the first conductive layer 106 on it) and the second insulation layer 128 (having the 3rd conductive layer 132 on it), as shown in Figure 1, Figure 2, Figure 3 and Figure 4.Patterning interlayer 112 can be for example double-sided pressure-sensitive adhesive agent layer, layer of heat activated adhesive or heat setting bonding agent plastic layer.The thickness range of patterning interlayer 112 can be for example approximately 50 microns to approximately 300 microns, preferably between approximately 75 microns and approximately 150 microns.The entire length of analytical test strip 100 can be in the scope of for example 30mm to 50mm, and width can be in the scope of for example 2mm to 5mm.
Reagent layer 134 can be any suitable reagent mixture, analyte in itself and body fluid sample (for example, glucose) carry out selective reaction, to form electroactive substance, then can carry out quantitative measurment to it according to the electrode place of the analyte testing bar of the embodiment of the present invention.Therefore, reagent layer 138 can comprise at least medium and enzyme.The example of suitable medium comprises the hexacyanoferrate, ferrocene, ferrocene deriv, osmium bipyridine mixture and quinone derivative.The example of suitable enzyme comprises: glucose oxidase; Hexose phosphate dehydrogenase (GDH), it uses pyrroloquinoline quinone (PQQ) cofactor; GDH, it uses Reduced nicotinamide-adenine dinucleotide (NAD) cofactor; And GDH, it uses flavin adenine dinucleotide (FAD) cofactor.Can be with appointing suitable technology to form reagent layer 134.
With reference to Fig. 6, Fig. 7 and Fig. 8, if needed, analytical test strip 100 can also comprise at least one integrated carrier sheet, and it is only configured to user's handle.In the embodiment of Fig. 6 to Fig. 8, analytical test strip 100 comprises the first integrated carrier sheet 140 and the second integrated carrier sheet 142.In addition, a part for the first insulation layer, the first conductive layer, patterning interlayer, the second insulation layer and the second conductive layer is arranged between the first integrated carrier sheet 140 and the second integrated carrier sheet 142.The first integrated carrier sheet 140 is arranged so that the pad that electrically contacts that electrically contacts pad and patterning interlayer of the first conductive layer is exposed.This exposure allows to electrically contact with experiment tester during use.
Can for example be comprised by any suitable material, paper, fiber board or plastic material form the first integrated carrier sheet and the second integrated carrier sheet.Because the first integrated carrier sheet and the second integrated carrier sheet are only configured to user's handle in the embodiment providing, can form these carrier-pellets by relatively inexpensive material.
Figure 10 is the schema that each stage of for example, method 1000 for determining analyte in body fluid sample (, whole blood sample) (such as, glucose) is shown.Method 1000 comprises to be introduced body fluid sample in the sample receiving chamber of analytical test strip, and described analytical test strip has the first electrode part of the first conductive layer and the second electrode part (referring to the step 1010 of Figure 10) of the 3rd conductive layer.In addition, the first electrode part and the second electrode part are divided into relativeness.
In the step 1020 of method 1000, electrically contact pad the electroresponse that electrically contacts pad and measure the first electrode part and the second electrode part via the second conductive layer of the patterning interlayer of analytical test strip via the first conductive layer.Patterning interlayer is arranged between the first conductive layer and the 3rd conductive layer.In addition, the pad configuration that electrically contacts of the first conductive layer and the second conductive layer becomes unidirectional stacked relation, and the second electrode part and the second conductive layer electrically contact pad electric connection.
Method 1000 is also included in the electroresponse based on measured in step 1030 and determines analyte.
Once the disclosure of learning, those skilled in the art just will recognize, can easily improve method 1000, with combination according to any technology, beneficial effect and the characteristic of embodiments of the invention and analytical test strip as herein described.
Although show herein and described the preferred embodiments of the present invention, it will be apparent for a person skilled in the art that this type of embodiment only provides by way of example.Those skilled in the art now will not depart from the present invention and expect multiple variation, change and replacement scheme.The multiple alternative form that it should be understood that the embodiment of the present invention described herein can be used for enforcement of the present invention.Determine and think, below claims limit scope of the present invention, fall into equipment and method and their equivalent within the scope of these claims thereby cover.

Claims (19)

1. the analytical test strip using together with experiment tester, described analytical test strip comprises:
The first insulation layer, it has the first insulation layer upper surface;
The first conductive layer, it is arranged on described the first insulation layer upper surface and comprises: the first electrode part; With
At least one electrically contacts pad, itself and described the first electrode part electric connection; Patterning interlayer, it is arranged on described the first conductive layer top and comprises:
Distal part, it is limited to the body fluid sample receiving chamber of described the first electrode part of covering wherein; With
Insulation portions of proximal, it has upper surface and is arranged on the second conductive layer on described upper surface, and described the second conductive layer comprises:
Interlayer contact part; With
Electrically contact pad;
The second insulation layer, it is arranged on described patterning interlayer top and has the second insulation layer lower surface;
The 3rd conductive layer, it is arranged on described the 3rd insulation layer lower surface and comprises:
The second electrode part; With
Portions of proximal, it covers described interlayer contact part;
Wherein said the second electrode part is divided and is arranged to cover and is exposed to described sample receiving chamber and is divided into relativeness with described the first electrode part, and
The operationally juxtaposition of described interlayer contact part of the described portions of proximal of wherein said the 3rd conductive layer and described the second conductive layer, makes between pad, to have electrical connection electrically contacting described in the described second electrode part of described the 3rd conductive layer and described patterning interlayer using during described analytical test strip.
2. analytical test strip according to claim 1, the described portions of proximal of wherein said the 3rd conductive layer is by the operationally juxtaposition of described interlayer contact part of gap and described the second conductive layer, and
Operationally closure is carried out by compress described analytical test strip in the time inserting in described experiment tester in wherein said gap, the described portions of proximal of described the 3rd conductive layer and the interlayer contact part of described the second conductive layer is had and be electrically connected.
3. analytical test strip according to claim 1, also comprises conductive adhesive layer, and
The described portions of proximal of wherein said the 3rd conductive layer is by the operationally juxtaposition of described interlayer contact part of described conductive adhesive layer and described the second conductive layer.
4. analytical test strip according to claim 1, the described portions of proximal of wherein said the 3rd conductive layer is by electrical fused joint and operationally juxtaposition of described interlayer contact part therebetween.
5. analytical test strip according to claim 1, wherein said analytical test strip is based on electrochemical analytical test strip.
6. analytical test strip according to claim 1, also comprises at least one integrated carrier sheet, and it is only configured to user's handle.
7. analytical test strip according to claim 6, wherein said analytical test strip comprises the first integrated carrier sheet and the second integrated carrier sheet, and
At least a portion of wherein said the first insulation layer, described the first conductive layer, described patterning interlayer, described the second insulation layer and described the second conductive layer is arranged between described the first integrated carrier sheet and described the second integrated carrier sheet.
8. analytical test strip according to claim 7, a pad that electrically contacts that electrically contacts pad and described patterning conductor layer that is arranged so that described the first conductive layer in wherein said the first integrated carrier sheet and described the second integrated carrier sheet is exposed.
9. analytical test strip according to claim 1, the wherein said analyte of determining in body fluid sample that is configured for based on electrochemical analytical test strip.
10. analytical test strip according to claim 9, wherein said analyte is glucose.
11. analytical test strips according to claim 9, wherein said body fluid sample is whole blood sample.
12. 1 kinds of methods for the analyte of definite body fluid sample, described method comprises:
Body fluid sample is introduced in the sample receiving chamber of analytical test strip, described sample receiving chamber has the first electrode part of the first conductive layer and the second electrode part of the 3rd conductive layer therein, and described the first electrode part and described the second electrode part are divided into relativeness;
Electrically contact pad the pad that electrically contacts via the second conductive layer of the patterning interlayer of described analytical test strip via described the first conductive layer, measure the electroresponse of described the first electrode part and described the second electrode part, described patterning interlayer is arranged between described the first conductive layer and described the 3rd conductive layer, and
Wherein said the first conductive layer electrically contact pad and described the second conductive layer is configured to unidirectional stacked relation, and
Wherein said the second electrode part and described the second conductive layer electrically contact pad electric connection; And
Described analyte is determined in electroresponse based on measured.
13. methods according to claim 12, wherein said analytical test strip is based on electrochemical analytical test strip.
14. methods according to claim 13, wherein said analyte is glucose.
15. methods according to claim 13, wherein said body fluid sample is whole blood sample.
16. methods according to claim 12, wherein said analytical test strip comprises at least one integrated carrier sheet, it is only configured to user's handle.
17. methods according to claim 16, wherein said analytical test strip comprises the first integrated carrier sheet and the second integrated carrier sheet.
18. methods according to claim 17, a pad that electrically contacts that electrically contacts pad and described patterning conductor layer that is arranged so that described the first conductive layer in wherein said the first integrated carrier sheet and described the second integrated carrier sheet is exposed.
19. methods according to claim 12, the wherein said analyte of determining in body fluid sample that is configured for based on electrochemical analytical test strip.
CN201380012160.1A 2012-03-02 2013-03-01 With the test strip for stacking unidirectional contact Active CN104160035B (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US13/410609 2012-03-02
US13/410,609 US9217723B2 (en) 2012-03-02 2012-03-02 Co-facial analytical test strip with stacked unidirectional contact pads
PCT/EP2013/054216 WO2013128021A1 (en) 2012-03-02 2013-03-01 Test strip with stacked unidirectional contact

Publications (2)

Publication Number Publication Date
CN104160035A true CN104160035A (en) 2014-11-19
CN104160035B CN104160035B (en) 2017-04-05

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US (2) US9217723B2 (en)
EP (1) EP2820143B1 (en)
JP (1) JP2015508900A (en)
KR (1) KR20140137410A (en)
CN (1) CN104160035B (en)
AU (1) AU2013224918B2 (en)
CA (1) CA2865458C (en)
ES (1) ES2623505T3 (en)
HK (1) HK1205766A1 (en)
IN (1) IN2014DN07232A (en)
RU (1) RU2014139824A (en)
WO (1) WO2013128021A1 (en)

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